Leaflet: information for the user

Olanzapina MABO 15 mg buccal dispersible tablets EFG

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1. What isOlanzapina MABOand what is it used for

2. What you need to know before you start takingOlanzapina MABO

3. How to takeOlanzapina MABO

4. Possible side effects

5. Storage ofOlanzapina MABO

6. Contents of the pack and additional information

Olanzapina MABOtabletsbelongs to a group of medicines called antipsychotics.

OlanzapinaMABOis used to treat:

- schizophrenia, a condition with symptoms such as hearing, seeing or feeling things that are not real, false beliefs, unusual suspicion, and a tendency to withdraw. People who suffer from these conditions may also be depressed, anxious or tense.

-Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria,an illness characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep than usual, speaking very quickly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the occurrence of extreme mood variations associated with this illness.

- This medicine has shown that it prevents the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take OlanzapinaMABO

• if you are allergic to Olanzapina or any of the other components of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, tell your doctor.
• if you have previously been diagnosed with narrow-angle glaucoma (increased eye pressure)

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• do not recommend the use of this medication in elderly patients with dementia as it may have severe adverse effects.
• medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina, tell your doctor
• very rarely, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens, contact your doctor immediately.
• weight gain has been observed in patients taking this medication. You and your doctor should check your weight regularly. If necessary, your doctor may help you plan a diet or refer you to a nutritionist.
• high levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking this medication. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Olanzapina and regularly during treatment.
• if you or a family member has a history of blood clots, consult your doctor, as medications of this type have been associated with blood clot formation.

If you have any of the following conditions, tell your doctor as soon as possible:

• stroke or transient ischemic attack (temporary lack of blood flow to the brain)
• parkinson's disease
• prostate problems
• intestinal blockage (paralytic ileus)
• liver or kidney disease
• blood disorders
• heart disease
• diabetes
• seizures
• if you think you may have electrolyte loss due to prolonged diarrhea and vomiting or the use of diuretic medications (water pills)

If you have dementia, you or your caregiver or family member should inform your doctor as it may have severe adverse effects.

If you have ever had a stroke or transient ischemic attack.

As a routine precaution, if you are over 65 years old, it would be a good idea for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapina.

Other medications and Olanzapina Mabo

Only take other medications at the same time as Olanzapina if your doctor authorizes it. You may feel drowsy if you combine Olanzapina with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including over-the-counter medications.

Inform your doctor especially if you are taking

• medication for Parkinson's disease.
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). You may need to adjust your dose of this medication.

Taking Olanzapina with food and drinks

OlanzapinaMABO tabletscan be taken with or without food.

Do not take alcoholic beverages during treatment with Olanzapina MABO tablets. The combination of Olanzapina and alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take this medication while breastfeeding as small amounts of Olanzapina

may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with Olanzapina in the last three months of pregnancy (last three months of pregnancy):

shaking, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Driving and operating machinery

There is a risk of drowsiness when taking Olanzapina. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

Olanzapina MABO contains aspartame

This medication contains 8.4 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions for Olanzapina MABO as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many tablets of this medication you should take and for how long. The daily dose of Olanzapina ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapina unless your doctor tells you to.

You should take your Olanzapina tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. Olanzapina tablets are for oral administration.

Do not interrupt treatment when you think you are feeling better. It is very important that you continue taking Olanzapina as long as your doctor tells you to.

Olanzapina MABO tablets are prone to breaking easily, so they must be handled with care. Do not handle the tablets with wet hands because they can disintegrate.

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently through the perforations that surround it.

2. Remove the back of the cell gently.

3. Carefully extract the tablet.

4. Place the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.

You can also place the tablet in a cup or a glass filled with water, orange juice, apple juice, milk, or coffee, stirring it. With some drinks, the mixture may change color and become cloudy. You should drink it immediately.

If you take more Olanzapina MABO than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Patients who have taken more Olanzapina than they should have experienced the following symptoms: rapid heartbeats, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and reduced consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the packaging with the tablets to the doctor.

If you forgot to takeOlanzapina MABO

If you forgot to take a dose of Olanzapina, continue the treatment with the normal dose. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withOlanzapina MABO

Do not interrupt treatment without consulting your doctor first, even if you feel better. It is very important that you continue taking this medication as long as your doctor tells you to. Treatment interruption should be done gradually and always following the doctor's instructions.

If you stop taking this medication suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Olanzapina may cause side effects, although not everyone will experience them.

Immediately contact your doctor if you have:

-unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue, tremors.

-blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, see your doctor immediately.

-a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data)

Frequent side effects (which can affect more than 1 in 10 people) include weight gain; drowsiness; and increased blood prolactin levels. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This feeling usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes; increased blood sugar and urine levels; increased blood uric acid and creatine phosphokinase levels; increased appetite; dizziness; agitation; tremors; strange movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention causing inflammation of the hands, ankles, or feet; fever; joint pain; and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (which can affect up to 1 in 100 people) include hypersensitivity (e.g. inflammation of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma; seizures, in most cases related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless leg syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nasal bleeding; abdominal distension; loss of memory or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or decrease of menstrual periods and changes in the breast gland in men and women such as abnormal milk production or abnormal growth, excessive salivation.

Rare side effects (which can affect up to 1 in 1000 people) include a decrease in normal body temperature; abnormal heart rhythm; sudden death without apparent explanation; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and white parts of the eye; muscle disorder that presents as unexplained pain and prolonged and/or painful erection.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS by its English acronym). Initially, DRESS manifests with symptoms similar to the flu with a rash on the face and later, with extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of a type of white blood cell (eosinophilia).

During treatment with Olanzapina, elderly patients with dementia may experience stroke, pneumonia, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.

Olanzapina may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use (Website:www.notificaram.es)By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Storage Conditions:

Blister: No special storage conditions required

Do not use Olanzapina MABO after the expiration date shown on the packaging.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy.In case of doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

Composition ofOlanzapina MABO

• The active ingredient is Olanzapina. Each buccal dispersible tablet contains 15 mg of Olanzapina.

-The other components (excipients) are: heavy magnesium carbonate, microcrystalline cellulose, crospovidone, microcrystalline cellulose, and guar gum, aspartame E951, low-substitution hydroxypropyl cellulose, orange flavor, anhydrous colloidal silica, magnesium stearate, L-methionine.

Appearance of the product and contents of the packaging

OlanzapinaMABO15 mg is presented in the form of buccal dispersible tablets. The tablets are yellow, round, and biconvex, marked with a ‘O2’ on one face.

Packaging sizes:

Non-divisible blister pack of Al/Al with 28 individual tablets.

Perforable blister pack divisible into individual doses of Al/Al with 28 tablets.

Marketing authorization holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 CosladaMadrid

Spain

Responsible for manufacturing

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Last review date of this leaflet: September 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/